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临床试验/CTRI/2025/08/092828
CTRI/2025/08/092828尚未招募不适用

Role of Observation in Making Totality of Symptoms in Acute Rhinitis in Pediatric Age Group 5– 15 Years Age

C D Pachchigar College Of Homoeopathic Medicine And Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年8月21日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To evaluate the role of observation in accurately identifying and formulating the totality of symptoms in pediatric patients aged 5 to 15 years presenting with acute rhinitis, in order to support individualized diagnosis and effective management through a holistic, symptom-based approach.

研究概览

简要总结

6

BRIEF RESUME OF INTENDED WORK

|6.1

NEED FOR STUDY

Worldwide, the burden of respiratory disease has dramatically increased, endangering public health. Infections of the upper respiratory tract are among the most common diseases in primary medical care. Although those conditions are often self-limited and non-fatal, the symptoms can significantly impair life quality and productivity. (1) Respiratory tract infections are the main cause of children’s morbidity and mortality both in developing and the developed countries, and among all the conditions, Acute Rhinitis is the most common respiratory condition with high prevalence and maximum recurrency, it presents unique challenges in pediatric populations while typically mild in adults impacting the quality of life of both children and their caregivers.

 A recent paediatric survey of children 4-17 years old conducted in the United States showed that rhinitis affects the quality of life (work and sleep) of sufferers and their caregivers (2), results in many leaves in schools and jobs which is also affecting the country economically.

 Acute rhinitis commonly results from viral infections but may also be a result of allergies, bacteria, or other causes. (3)Acute rhinitis manifests with a spectrum of symptoms ranging from nasal congestion and rhinorrhea to cough, fever, and malaise. Moreover, pediatric patients may exhibit atypical symptoms or subtle clinical signs, necessitating a comprehensive assessment. Through meticulous observation, clinicians can discern subtle variations in symptomatology, facilitating a more accurate diagnosis and tailored management approach. Homeopathy places particular emphasis on identifying key characteristics and modalities associated with each symptom experienced by the patient.

 Hahnemann emphasizes the importance of observation in clinical practice. Observations often exposes the peculiarity of the patient and therefore demands making summary of such observations after noting the symptoms expressed by the patient and their caretaker (Guardians) and also observed by the physician. In Organon of medicine the place of observation in the examination of a case is stated as “The state of the disposition of the patient often chiefly determines the selection of the homoeopathic remedy, as being a decidedly characteristic symptom, which can least of all remain concealed from the accurately observing physician.” Hahnemann (1833) (4)

Clinical judgment, informed by careful observation, is indispensable in the evaluation of pediatric patients with acute rhinitis. Unlike adults who can articulate their symptoms more clearly, children often rely on non-verbal cues, necessitating astute observation by healthcare providers. Observation plays a pivotal role in assessing the overall state of the pediatric patient, including their temperament, behavior, and response to environmental stimuli. Through meticulous observation, homeopathic practitioners can ascertain peculiarities such as the timing of symptom onset, aggravating or ameliorating factors, and concomitant symptoms. These key characteristics serve as valuable clues in selecting the simillimum, the remedy that closely matches the totality of the patient’s symptoms.

 By selecting the simillimum based on the comprehensive understanding of the patient’s symptomatology, homeopathic practitioners aim to stimulate the body’s inherent healing mechanisms and restore balance at the physical, mental, and emotional levels to promote recovery and prevent recurrence.

 Further research is needed to validate the efficacy of homeopathy in treating acute rhinitis and understand its mechanisms of action. A systematic study on the role of observation in assessing symptom totality in pediatric patients can contribute to this effort and enhance evidence-based practice.

6.2

REVIEW OF LITERATURE

INTRODUCTION

Rhinitis refers to any kind of inflammatory condition of the nasal mucosal linings. Generally, acute rhinitis is associated with environmental allergies or respiratory viral infections. Viral microbes with numerous types and subtypes can infect the respiratory epithelium of the nasal cavity in a repetitive fashion throughout the year, or during a specific period of time such as winter or fall. (5)

 Acute Rhinitis is often short-lived inflammation of the mucous membrane of the nose that is caused by a variety of viruses, usually common cold. It occurs both in children as well as adults. Children may suffer 4-6 episodes whereas adults may suffer 3 episodes of Acute Rhinitis per year. (6)

 TYPES (3)(7)(8)

There are several types of rhinitis. The most common are acute rhinitis, which is usually caused by a viral illness, allergic or seasonal rhinitis, and nonallergic or year-round rhinitis.(7) Rhinitis is classified as allergic or nonallergic. The cause of nonallergic rhinitis is usually a viral infection, although irritants can cause it. The nose is the most commonly infected part of the upper airways. Rhinitis may be acute (short-lived) or chronic (long-standing). (3)

 Rhinitis may be classified as follow:(8)

 1)    INFECTIVE RHINITIS

Acute Rhinitis

Non-specific: Common cold

Specific: Diphtheria

 Chronic Rhinitis

 2)    NON-INFECTIVE RHINITIS

 Allergic

Seasonal

Perennial

Vasomotor

 ETIOLOGY(7)(9)

The most common causes of rhinitis are,

 Pollen given off by trees, grass, and weeds, Dust mites, Mold, Cockroach waste, Animal dander, Fumes and odors, Temperature, Hormonal changes, Certain medicines and overuse of topical nose sprays, Changes in the environment, Smoke, Certain foods or spices etc.(7)

 Acute rhinitis triggers can be allergic or non-allergic. Non-allergic triggers include infections, medication or occupational factors such as exposure to irritants such as wheat in mills or when baking, which can lead to symptoms of both rhinitis and asthma. (9)

 Allergic triggers can be differentiated by the duration of the symptoms: whether perennial (year-round) or seasonal or whether there is an association with being indoors or outdoors. Indoor environmental allergens that are perennial are house dust mite, and cat and dog dander. House dust mite allergy tends to be worse at the coast as opposed to the dryer Highveld as mites need ambient humidity to procreate and grow. However, what has emerged is that even perennial indoor allergens can cause exacerbations of rhinitis when individuals become house-bound as has occurred during the coronavirus disease 2019 (COVID-19) ‘lockdown’. In addition, in winter periods, when indoor living coincides with winter bedding taken out of storage, exacerbations of AR may occur even in mid-winter, outside of the pollen season. (9)

 TYPES OF ACUTE RHINITIS(9)

TYPE

AETIOLOGY

|Viral Rhinitis

Most likely viral infection if symptoms less than 2 weeks

|Seasonal Rhinitis

Correlates with outdoor allergens such as grass, tree and weed pollen, and Alternaria and Cladosporium (mold)

|Pollution spike

Increased indoor pollution: prolonged time spent indoors, fires, gas stoves, pets, air conditioner filters

Increased outdoor pollution (9)

 PREVALENCE

Regarding the worldwide prevalence of rhinitis among children, the International Study of Asthma and Allergies in Childhood (ISAAC), which is considered as the landmark study in this field, reported in 2004 a prevalence of self reported current nasal symptoms of 31.7 percent (ranging from 11.9 percent to 80.6 percent) based on data from 97 countries.(10) Acute rhinitis, allergic and/or non-allergic, is common and will affect all people at some time. The onset is abrupt and usually lasts for a couple of days. Children are especially vulnerable and episodes occur up to four times more frequently when compared with adults. Events are often perceived as trivial and self-limiting but may become very troublesome. It is particularly important to recognize and manage them appropriately when acute exacerbations are due to allergy. (9)

 Children who are younger than 2 years of age will often be thought to have a viral infection (a common cold) rather than acute AR. (9)

PREVALANCE OF COMMON COLD/AVR (Acute Viral Rhinitis)(5)(11)(12)

The common cold, also called viral rhinitis, is one of the most common infectious diseases in humans. The infection is usually mild and improves without treatment. Because of the large number of people who get the common cold, this illness results in more than 22 million days of missed school and an even greater number of absent days from work every year in the United States. The average American has 1 to 3 colds per year. (12)

 The common cold is an upper respiratory infection that is caused by several families of viruses. Within these virus families, more than 200 specific viruses that can cause the common cold have been identified. The virus family that causes the most colds is called rhinovirus. Rhinoviruses cause up to 40 percent of colds, and this virus family has at least 100 distinct virus types in its group. Other important upper respiratory virus families are named coronavirus, adenovirus and respiratory syncytial virus. Since so many viruses can cause cold symptoms, development of a vaccine for the common cold has not been possible.(12)

 Rhinoviruses cause most colds in the early fall and spring. Other viruses tend to cause winter colds and their symptoms can be more debilitating. There is no evidence that going out in cold or rainy weather makes you more likely to catch a cold.(12)

 Young children have an average of 6-8 colds per year, but 10–15 percent of children have at least 12 infections per yr. The incidence of illness decreases with increasing age, with 2-3 illnesses per year by adulthood. Children in out-of-home daycare centers during the 1st year of life have 50 percent more colds than children cared for only at home.(11)Risk of experiencing AVR in a single year is much more probable for children than adults. While children experience 8–12 colds a year, adults usually experience 2–3 colds per year.(5)

PREVALENCE OF ALLERGIC RHINITIS

India is the second most populous country (1·35 billion people) in the world and is classified as a lower-middle income country. Nearly 20 percent of the world’s population live in India. An Indian study reported that prevalence of allergic rhinitis was 11·3 percent in children aged 6–7 years, and 24·4 percent in children aged 13–14 years. Allergic rhinitis affected all pediatric age group and was peaked at age group 11–14 years and 5–7 years. Allergic rhinitis was recorded as the one and only allergic disease in 59 percent of the children diagnosed with allergic rhinitis, concomitant asthma in 16 percent of them, atopic dermatitis in 8 percent and allergic conjunctivitis in 5 percent. 54 percent of asthmatic children was diagnosed allergic rhinitis, while 16 percent of allergic rhinitis children was diagnosed asthma.(13)

SYMPTOMS AND DIAGNOSTIC CRITERIA

Symptoms consist of runny nose, sneezing, congestion, postnasal drip, cough, and very rare low-grade fever.

SYMPTOMS SEEN IN COMMON COLD(8)

There are 4 stages of common cold:

 Ischemic Stage (After an incubation period of 1 to 3 days)

(1) Burning in the nasopharynx may be the first symptom.

(2) Irritation and dryness in the nose soon follow.

(3) Sneezing occurs paroxysmal.

(4) Shivering and malaise may develop.

 Hyperemic Stage

(1)  Rhinorrhea becomes profuse.

(2) Blocking of the nose occurs. The mucosa is hyperemic

(3) Anosmia may be present.

(4) Fever and headache may be present.

 Stage of Secondary Infection

Discharges becomes yellow or greenish, and thickens.

 Stage of Resolution

It occurs in 5 to 10 days.

 SYMPTOMS OF ACUTE EXACERBATION OF ALLERGIC RHINITIS (9)(8)

 Acute AR is usually associated with paroxysms of sneezing, anterior and posterior rhinorrhea, nasal obstruction and nasal itch. The complaint of ‘itch’ is often prominent in acute allergic rhinitis and patients may also report itching of the palate and eyes (sometimes with tears). Troublesome symptoms such as sleep-disrupting breathing and impairment of daily activities will be noted in more severe disease. Children are often not efficient at nasal clearance. (9)

 Symptoms like:(8)

Irritation in the nose is the initial symptom.

Paroxysmal Sneezing of recurrent type is usually present, which exhausts the patient.

Rhinorrhea is watery and copious.

Nasal Obstruction due to venous stasis is often present.

Anosmia may be present intermittently or continuously.

Headache can be present

 In Acute Stage: The mucosa appears to be pale with excessive mucoid or watery secretions as a sign of acute rhinitis(8)

EVALUATING PATIENTS FOR ACUTE RHINITIS(14)

  | PATHOPHYSIOLOGY(15)

Humans normally produce about 2 L of mucus per day from their nasal lining. The nose functions primarily as a humidification and filtration system, with a clean and refreshed nasal mucous blanket serving to trap particulate matter and organisms. The nasal and sinus lining consists of ciliated respiratory epithelium; the cilia function in a highly organized and orderly fashion under normal circumstances to transport particulate matter trapped in the mucous blanket in a consistent fashion so that the mucus can be swallowed, thereby avoiding deposition in the bronchi. The nose also serves as the organ of olfaction to allow patients to discern tastes and avoid spoiled foods that could cause illness.(15)

The parasympathetic nervous system controls both vascular tone and mucus production in the nose. Inflammatory conditions, such as the common cold, can cause the nasal and sinus lining to swell, thus highlighting the nasal cycle governed by parasympathetic neural control. In a normal state, one side of the nose is relatively decongested and one side is relatively congested because of vascular engorgement. This vascular dilation allows humidification and warming of inspired air and can also affect the ability to discern odors in the process of olfaction. During rhinitis, the inflammation exaggerates the normal relative comparison between the decongested and congested sides of the nose and can be perceived as an uncomfortable nasal stuffiness that shifts from side to side over a period of several hours.(15)

DIAGNOSIS(15)

A thorough history should probe whether patients have tried over-the- counter or prescription medications, as many medications have side effects that affect nasal physiology. Specific questions regarding allergies are important, including seasonality or environmental triggers, the presence or absence of pets, food sensitivities, recent changes in environment, and living conditions, with a focus on old or new carpets, mattresses, furnace filters, or freshly painted interior walls. (15)

A recent history of other family members or coworkers being ill suggests an infectious process. An astute physician often suspects an infectious process by noting the similarity and time course of symptoms in other patients; this information can be related to patients so that they know what to expect in terms of time course and recovery. A careful past medical history should allow one to determine whether relevant conditions such as previous nasal surgery or trauma, granulomatous diseases, cystic fibrosis, rheumatologic conditions, immune deficiencies, or other problems may be contributing factors. Unilateral nasal congestion raises concern for either an anatomic abnormality, such as septal deviation, perhaps related to previous trauma, a polyp or other neoplastic mass, or perhaps even a foreign body.(15)

CONDITIONS****THAT CAN MIMIC RHINITIS(14)

A number of conditions can produce the same signs and symptoms as rhinitis. Some of these conditions are relatively rare. Structural conditions that may mimic rhinitis include deviated septum, nasal tumors, enlarged adenoids, and hypertrophic turbinate. Immunologic conditions include Wegener’s granulomatosis, sarcoidosis, relapsing polychondritis, Sjögren’s syndrome, and midline granuloma. (14)

HOMOEOPATHIC CONCEPT OF OBSERVATION IN MAKING TOTALITY OF SYMPTOMS

“If the Homoeopathic Physician is not an accurate observer, his observations will be indefinite, and his observations are indefinite, his prescribing is, indefinite” Kent (1900) (4)(16)

Master Samuel Hahnemann considers healing of the sick and suffering as the most superior of all human vocations. Through clear guidelines and instructions, Hahnemann guides physicians to the road of becoming true healer of diseases. Careful observation is one of the skills Hahnemann demands from fellow homoeopaths in order to perceive each individual case in its accurate way so that he can deliver the best as a true healer.(17)

Observation means the act or instance of noticing a condition, perception, the faculty of taking notice, the accurate watching and noting of a phenomenon. (Oxford Dictionary) When a patient comes for consultation a medical practitioner is likely to take note her/his sex, apparent age, constitution, posture, state of nutrition, facies, manner of dress, talking and other similar features. Many at times, observation along with the other symptomatology stated by the patient determines the remedy. As such, good observational skill remains to be one of the requisite qualities of a homoeopathic practitioner. (4)

In the 6th and 83rd aphorism Hahnemann demands from physicians, for each individual case, nothing but freedom from prejudice and sound senses, attention in observing and fidelity in tracing the picture of the disease.(17)

In the aphorism 90, detailed practical instructions to be followed during case taking are mentioned. “*When the physician has finished writing down these particulars, he then makes a note of what he himself observes in the patient, and ascertains how much of that was peculiar to the patient in his healthy state.”*In the footnote to this aphorism, master gives some examples like, “How the patient behaved during the visit – whether he was morose, quarrelsome, hasty, lachrymose, anxious, despairing or sad, or hopeful, calm etc. What was the color of his face and eyes, and of his skin generally? Were his pupils dilated or contracted? What was the character of the pulse?(17)

In one of his very interesting articles – ‘The Medical Observer’ (1825), Hahnemann says, in order to be able to observe well, the medical practitioner requires to possess the capacity and habit of noticing correctly the phenomenon that takes place in natural diseases, as well as those that occur in the morbid states excited artificially by medicines when they are tested upon healthy body. Hahnemann clearly states that, the capability of observing accurately is never an inborn or hereditary faculty; it must be chiefly acquired by practice, by refining and regulating the perception of the senses.(17)(18)

S. Hahnemann emphasizes the importance of observation in clinical practice. Observations often exposes the peculiarity of the patient and therefore demands making summary of such observations after noting the symptoms expressed by the patient. In Organon of medicine the place of observation in the examination of a case is stated as “The state of the disposition of the patient often chiefly determines the selection of the homoeopathic remedy, as being a decidedly characteristic symptom, which can least of all remain concealed from the accurately observing physician.” Hahnemann (1833)(4)(19)

According to Hahnemann ‘the expression of the disease in the sensations and functions of the side of the organism exposed to sense of the physician and bystanders.(4)Hereby, observation includes not only the symptoms which are observed by the physician into the Patient but also the symptoms which are observed by the people and caregiver present around the patient.

Hahnemann ends the article, The Medical Observer by stating that, “true is that the careful observer alone can become a true healer of diseases.”(17)(18)

|6.3

OBJECTIVE OF THE STUDY

The objective of this thesis is to investigate the role of observation in forming the totality of symptoms in acute rhinitis among pediatric patients aged 5-15 years.

     |

 

7

MATERIAL AND METHODS:

|7.1

SOURCES OF DATA

PROJECT SITE

Institutional Out Patient Department.

Camps arranged by the institute.

|7.2

MATERIALS

Case records from institute.

|7.3

METHOD OF COLLECTION OF DATA

1.    Study Design: Observational study

2.    Study Type: Prospective study

3.    Study Population: Children age 5-15 years, including both sexes

4.    Sample Size: 60 Cases

5.    Sample Techniques: Simple Random Sampling

6.    Selection Criteria:

 Inclusion criteria

1.    Age Range: Pediatric patients aged between 5 to 15 years.

2.    Sex: Both sexes are included

Exclusion criteria:

1.    Age: Patients outside the specified age range (less than 5 years old or greater than 15 years old).

2.    Patients with chronic rhinitis or other chronic respiratory conditions (eg. COPD, Tuberculosis)

3.    Patients with severe complications (e.g., Pneumonia, Fibrosis etc.) or comorbidities (e.g., ADHD, ODD) that may affect symptom presentation or observation.

4.    Patients with congenital abnormalities (e.g., Down Syndrome, Fragile X syndrome, Juvénile Diabètes etc.) and other deep Respiratory Pathologies.

7.4

DOES THE STUDY REQUIRING ANY INVESTIGATION TO BE CONDUCTED ON PATIENTS OR OTHER HUMANS OR ANIMALS?

  No

|7.5

HAS    ETHICAL CLEARENCE BEEN OBTAINED FROM YOUR INSTITUTE?

 Yes

|

8

BIBLIOGRAPHY:

1.

Jin XaRJaLRaGYaZHaLJaZJaWXaWG. Global burden of upper respiratory infections in 204 countries and territories, from 1990 to 2019. EClinicalMedicine. 2021 June; 37: 100986.

|2.

Hardjojo AaSLPaVBHPaLBW. Rhinitis in children less than 6 years of age: Current knowledge and challenges. Asia Pacific Allergy. 2021 March; 1: 115-122.

|3.

Fried MP. MSD Manual. [Online].; 2023. Available from: https://www.msdmanuals.com/home/ear-nose-and-throat-disorders/nose-and-sinus-disorders/rhinitis.

|4.

K P. Scribd. [Online]. Available from: https://www.scribd.com/document/367771162/Value-of-Observations-in-Homoeopathic-Practice.

|5.

Çatli TaAHaMEK. Acute Viral Rhinitis. In Springer eBooks.; 2019. p. 199-202.

|6.

Jaipur Golden Hospital. [Online].; 2022. Available from: https://jghdelhi.net/diseases/acute-and-chronic-rhinitis/.

|7.

Hopkins J. Johns Hopkins Medicine. [Online].; 2023. Available from: https://www.hopkinsmedicine.org/health/conditions-and-diseases/rhinitis.

|8.

K.B.Bhargava SKBTMS. A Short Book of E.N.T Diseases for Medical Students and Practitioners. 11th ed.: Usha Publications; 2019.

|9.

Green RJaVNAaMMaFRaFCaRGaMF. Acute allergic rhinitis. South African Family Practice. 2020 October; 62.

|10.

Savouré MaBJaJJJKaJMSaJBaNR. Worldwide prevalence of rhinitis in adults: A review of definitions and temporal evolution. Clinical and Translational Allergy. 2022 March; 12.

|11.

Kliegman SGBSTW. Nelson Textbook of Pediatrics. 21st ed.: Elsevier; 2020.

|12.

LeWine HE. Harvard Health Publishing. [Online].; 2023. Available from: https://www.health.harvard.edu/a_to_z/common-cold-viral-rhinitis-a-to-z.

|13.

Krishna MTaMPAaVPaMSaMVaCDJ. An appraisal of allergic disorders in India and an urgent call for action. World Allergy Organization Journal. 2023 July; 13: 100446.

|14.

David M. Quillen DBF. Diagnosing Rhinitis: Allergic vs. Nonallergic. Am Fam Physician. 2006; 73: 583-1590.

|15.

Murr AH. Approach to the patient with ear, nose and throat disorders. In Goldman’s Cecil Medicine. 24th ed.: Elsevier; 2012.

|16.

Tyler KJ. Repertory of the Homoeopathic Materia Medica. 5th ed. New Delhi: B. Jain Publishers; 1945.

|17.

Homeo Book. [Online].; 2021. Available from: https://www.homeobook.com/observation-of-the-sick/.

|18.

R.E. D. In The Lesser Writings of Samuel Hahnemann. New Delhi: B. Jain Publisher; 2019. p. 724-728.

|19.

Hanhemann S. Organon of Medicine. 5th ed. New Delhi: B. Jain Publishers; 1833.

研究设计

研究类型
Observational

入排标准

年龄范围
5.00 Year(s) 至 15.00 Year(s)(—)
性别
All

入选标准

  • Pediatric Patients Aged Between 1 to 15 Years, Both Sexes Are Included.

排除标准

  • Patients outside the specified age range such as less than five year old or more than fifteen years old.
  • Patients with chronic rhinitis or other chronic respiratory conditions such as COPD or tuberculosis.
  • Patients with severe complications such as pneumonia or fibrosis or comorbidities such as ADHD or ODD that may affect symptom presentation or observation.
  • Patients with congenital abnormalities such as Down syndrome, Fragile X syndrome, juvenile diabetes, and other deep respiratory pathologies are excluded.

结局指标

主要结局

To evaluate the role of observation in accurately identifying and formulating the totality of symptoms in pediatric patients aged 5 to 15 years presenting with acute rhinitis, in order to support individualized diagnosis and effective management through a holistic, symptom-based approach.

时间窗: 9 Months

次要结局

  • To assess how clinical observation helps accurately identify all symptoms of acute rhinitis in children aged 5 to 15 years.(To evaluate how observation plays an important role in forming a complete understanding of acute rhinitis in Pediatric age group 5-15 years.)

研究者

发起方
C D Pachchigar College Of Homoeopathic Medicine And Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Rutvika Dhaneshkumar Patel

C D Pachchigar College Of Homoeopathic Medicine And Hospital

研究点 (1)

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